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Completed

NCT Number: NCT06882161

Clinical and Radiographic Evaluation of The Effect of Acetal Resin Versus PEEK on Supporting Structure of Abutment Teeth

This study was conducted to evaluate and compare the effect of acetal resin versus Polyether ether ketone (PEEK) partial dentures on abutment teeth supporting structures in Kennedy class I mandibular partial denture cases. Clinical assessments were conducted by assessing the pocket depth (PD), plaque index (PI), and gingival index (GI). Cone beam computed tomography (CBCT) was used to assess abutment alveolar bone height change.

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Key information

Age range

40 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Al-Azhar University

Cairo, Nasr City, 19519, Egypt

About this study

This study was a parallel, two-group, double-blinded, randomized clinical trial. The proposal and consents were approved by the Research Ethics Committee. (REC) approval (P-PD-14-14). The Helsinki Declaration's guiding principles were followed when conducting the study. The Comprehensive Standards of Reporting Trials Statement (CONSORT) checklist's structure is followed in the study's presentation. The study was carried out at the Outpatient Clinic of the Removable Prosthodontic Department within the Faculty of Dental Medicine for Girls at Al-Azhar University.

In this study, fifty patients were initially evaluated. After conducting clinical and radiographic assessments, twenty patients who satisfied the inclusion criteria were selected in accordance with the sample size calculation. Each patient received an explanation of every procedure, and informed consent was obtained. These twenty individuals were subsequently divided randomly into two distinct groups (ten in each):

Group I: Ten patients received polyoxymethylene (acetal resin) partial dentures designed and fabricated using CAD/CAM technology. Group II: Ten patients received polyether ether ketone (PEEK) partial dentures designed and fabricated using CAD/CAM technology.

All patients were evaluated clinically and radiographically. Clinical assessments were conducted by assessing the pocket depth (PD), plaque index (PI), and gingival index (GI) at denture insertion, three months later and six months later. Cone beam computed tomography (CBCT) was used to assess abutment alveolar bone height change at the time of denture placement, after three months, and after six months.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Every subject should be free of any systemic diseases that might influence the results of the research.
  • Patient's residual ridges should be covered with healthy mucosa.
  • Their salivary flow and viscosity for all within normal limits.
  • The patients are cooperative and ready to be called back as necessary.
  • had a Class I Angle's ridge relation

Exclusion criteria

  • Alcoholic or smokers' patients.
  • Patients with xerostomia or excessive salivation.
  • Patients with parafunctional habits.
  • Patients with ulcerated or inflamed mucosa.

Treatment and study plan

Acetal resin

Biological

Effect of acetal resin versus Polyether ether ketone (PEEK) partial dentures on abutment teeth supporting structures in Kennedy class I mandibular partial denture cases

Other names: PEEK

Primary outcomes

  1. Pocket Depth

    Time frame: 6 months

    assessing the pocket depth (PD) of abutment teeth

Secondary outcomes

  1. Plaque index

    Time frame: 6 months

    assessing the plaque index (PI) of abutment teeth

  2. Gingival index

    Time frame: 6 months

    assessing the gingival index (GI) of abutment teeth

  3. Abutment alveolar bone height change.

    Time frame: 6 months

    assessing the Abutment alveolar bone height of abutment teeth

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

Clinical and Radiographic Evaluation of The Effect of Acetal Resin Versus PEEK on Supporting Structure of Abutment Teeth in Mandibular Kennedy Class I Partial Dentures Manufactured by CAD-CAM Technology

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 18, 2025
Registry last updated
Mar 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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